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NCT06220201PHASE1Recruiting

A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With Relapsing Forms of Multiple Sclerosis, Progressive Forms of Multiple Sclerosis or Refractory Myasthenia Gravis (MG) (Breakfree-2)

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Start Date

3/28/2024

Completion Date

7/15/2027

Summary

The purpose of this study is to evaluate the safety, tolerability, efficacy, and drug levels of CC-97540 in participants with Relapsing Forms of Multiple Sclerosis (RMS), Progressive Forms of Multiple Sclerosis (PMS) or Refractory Myasthenia Gravis (MG).

Eligibility Criteria

Age Range: 18 years to 60 years

Inclusion Criteria \- Relapsing forms of Multiple Sclerosis (RMS) - Cohort 1. i) Participants must have an Expanded Disability Status Scale (EDSS) of ≥ 3.0 and ≤ 5.5. ii) Participants must have a diagnosis of Multiple Sclerosis (MS) with relapsed/refractory MS or conversion to active secondary progressive multiple sclerosis (aSPMS), and worsening of disease within 12 months prior to Screening and while on treatment with a high-efficacy DMT for at least 6 months. \- Progressive forms of MS - Cohort 2. i) Participants must have an EDSS ≥ 3.0 and ≤ 6.0. ii) Participants must have a diagnosis of primary progressive multiple sclerosis (PPMS) that is treatment-resistant or diagnosis of inactive secondary progressive multiple sclerosis (iSPMS). \- Myasthenia Gravis - Cohort 3 i)MGFA classification of II-IV at screening ii) Documentation of autoantibodies against AChR or MuSK (historical or at Screening) iii) Refractory disease defined as disease activity on at least 2 immunosuppressants, including steroids, NSIs, or biologics. iv) Has had thymectomy, only if indicated according to current guidelines. Exclusion Criteria * Cohorts 1 and 2: Participants that cannot complete the 9-Hole Peg Test (9-HPT) in at least 1 hand in \<240 seconds unless extenuating medical conditions unrelated to MS prohibit this. * Participants that cannot perform a Timed 25-Foot Walk Test (T25FWT) in \< 150 seconds. * Presence of other confounding peripheral nervous system disorders or other disorders that may impact muscle strength (eg, myositis) or cause weakness, stroke, chronic inflammatory demyelinating polyradiculoneuropathy, Lambert-Eaton myasthenic syndrome. * Other protocol-defined Inclusion/Exclusion criteria apply.

Interventions

DRUG

CC-97540

DRUG

Fludarabine

DRUG

Cyclophosphamide

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Conditions

Multiple SclerosisMyasthenia Gravis

Locations

Local Institution - 0011

Birmingham, Alabama 35294

United States

University of California, Irvine

Irvine, California 92697

United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado 80045

United States

Colorado Blood Cancer Institute

Denver, Colorado 80218

United States

Yale-New Haven Hospital

North Haven, Connecticut 06473

United States

University of Kansas Medical Center

Kansas City, Kansas 66160

United States

Local Institution - 0039

New Orleans, Louisiana 70121

United States

Local Institution - 0005

Boston, Massachusetts 02114

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

Neurological Institute of New York

New York, New York 10032

United States

University of Cincinnati Medical Center

Cincinnati, Ohio 45219

United States

Cleveland Clinic Mellen Center

Cleveland, Ohio 44195

United States

Oregon Health and Science University

Portland, Oregon 97239

United States

Swedish Medical Center

Seattle, Washington 98122

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

Antwerp University Hospital

Edegem, Antwerpen 2650

Belgium

UZ Gent

Ghent, Oost-Vlaanderen 9000

Belgium

Hopital Claude Huriez - CHU de Lille

Lille, Nord 59000

France

Pitie Salpetriere University Hospital

Paris, Ville de Paris 75013

France

Universitaetsklinikum Essen

Essen, North Rhine-Westphalia 45147

Germany

Universitaetsklinikum Magdeburg

Magdeburg, Saxony-Anhalt 39120

Germany

Local Institution - 0033

Düsseldorf, 40225

Germany

Universitaetsklinikum Erlangen

Erlangen, 91054

Germany

Klinikum der Universität München Großhadern

München, 81337

Germany

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona] 08035

Spain

Local Institution - 0016

Barcelona, Barcelona [Barcelona] 08035

Spain

Hospital Clínic de Barcelona

Barcelona, Catalunya [Cataluña] 08036

Spain

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Comunidad de 28034

Spain

Hospital Universitari i Politecnic La Fe

Valencia, 46026

Spain

Manchester Royal Infirmary

Manchester, Lancashire M20 2RZ

United Kingdom

University College London Hospital

London, London, City of NW1 2PG

United Kingdom

Salford Royal Hospital

Salford, Manchester M6 8HD

United Kingdom

Barts Health NHS Trust

London, E1 1RD

United Kingdom